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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K905074
Device Name MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM
Applicant
Siemens Gammasonics, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195
Applicant Contact DENNIS W HENKELMAN
Correspondent
Siemens Gammasonics, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195
Correspondent Contact DENNIS W HENKELMAN
Regulation Number892.1100
Classification Product Code
IYX  
Date Received11/09/1990
Decision Date 06/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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